isr_polymersomes_uclfandomcom-20200214-history
Meeting No. 5
__TOC__'Controversy 1:' Should animal testing be used in the development of nanomedicine? For: * Allows us to see how certain drugs affect humans * Many life saving treatments and cures have been developed thanks to animal testing ( polio vaccine ) * No adequate alternative to testing on living organisms * Some animals genetically similar to humans, so medicines can be tested on them instead of humans * Animal testing is highly regulated to prevent mistreatment of animals also the mistreatment of the animals leads to unreliable results so is discouraged. * Poll on animal testing by the Pew Research centre found that 89% of 3,748 scientists favoured the use of animals in research(1) * Animal testing has prevented the deaths of millions of animals due to many vaccines being developed which also benefit animals - rabies, tetanus, leukemia and many more Against: * It can be misleading, results not may not reliably predict the effect of a drug in humans * It is cruel and unethical e.g animals are often subjected to force feeding, food and water deprivation and the infliction of pain or disease. In particuar many experiments to test nanomedicines have been classified as moderately and severely distressful to the animals.(5) * Alternative testing methods such as studying cell cultures in vitro are available, these methods can also produce more reliable results as human cells can be used (2) * There is a potential that substances that are harmful or ineffective in animals may have a beneficial effect in human that is not seen if a drug is discarded at the animal testing stage * Even drugs that pass animal testing are not necessarily safe e.g Thalidomide which caused 10,000 babies to be born with severe birth defects was tested on animals before commercial release (4) Sources: (1)Carly Funk and Lee Rainie, "Public and Scientists' Views on Science and Society," pewinternet.org, Jan. 29, 2015 (2) Kara Rogers, "Scientific Alternatives to Animal Testing: A Progress Report," britannica.com, Sep. 17, 2007 (4) Science Museum (UK), "Thalidomide," sciencemuseum.org.uk (accessed Oct. 17, 2013) (5) ALTEX. 2009;26(2):109-28. 2''': Are we ready for human clinical trials? '''No: clinical trials are premature and unqualified * There is no standard regulatory framework for preparation, testing and characterisation of risks - so results into toxicology/ efficacy of nanomedicine are often inconclusive and conflicting * Nanoparticles have the potential to accumulate and persist in tissues e.g. Johannsen et al. (2007) showed nanoparticle deposits in prostate over 1 year after administration * Nanomedicine requires its own set of regulations as nanoparticles have unique properties owing to their small size and large surface area (e.g. high reactivity, high catalytic activity, quantum properties, super paramagnetism, strong surface adsorption properties) * Unpredictability of nanomaterials inside the organism - tiny variations in size and shape can have dramatic effects e.g. a study in the UK involving monoclonal antibodies lead to six subjects becoming critically ill after receiving the dose of antibody, that had produced no toxicity in animals * Lack of communication - subjects fail to understand the risks associated with clinical testing, and overestimate the benefits * We don't know enough about the environmental consequences Yes: human testing should commence in full * Animal studies have repeatedly been shown to be poor models for humans - it is pointless and dangerous to place so much faith in the extrapolation of these tests ** Animal studies use high dosage, short exposure time - not applicable to humans ** Fundamental differences in physiology, metabolism, genetics * There are already safety clinical regulations in place to minimise risk ** All materials for use in clinical trials will have had to have passed existing biocompatibility standards ** Close clincial monitoring of participants * In vivo animal experiments and ex vivo laboratory analyses can never eliminate all of the uncertainty surrounding the first exposure of a human subject to a particular nanoparticle - human testing is vital to have a complete understanding of risks before putting product on market Controversy 3: Who pays for research into nanomedicine? What are the issues? * Who pays for research into nanomedicine? The financial collapse, elevated costs associated with the R&D process, tricky access to funds, uncertainty over expected returns, and the lengthy FDA regulatory process have not deterred investors. Despite the problems, the potential of future developments in the different market segments, and possible high returns from high-risk innovation investments, make this market highly attractive. * Proposals, aiming to solve this issue The US accounts for a third of all publications, and half of patent filings, in nanomedicine research. A comparison with Europe shows that, while Europe is at the forefront of research, the US leads on the number of patent filings, indicating its more advanced commercialisation. (BCC Research, August 2014). What we learnt... Abdullah It was interesting to see the different viewpoints in regards to animal testing. Focusing on nanomedicine, I found that animal testing was a polarising topic with some strongly in favour and some strongly against it. I was able to use reliable sources using techniques learnt in previous sessions, in order to collect information on both sides of the argument. Adela Charlotte It was interesting to delve deeper into one specific area of controversy involved in nanomedicine. While doing my research on the issues involving human testing, I was often confronted to a paradox. The difficulty to predict the effect of certain nano materials on the human body and the uncertainty of in vitro experiments to show how the body will react to them makes human testing too dangerous... but also necessary, as the medicine could never be put on the market if its exact effects aren't known. Jasper Considering the challenges of the distribution of a new medicine is no easy task, due to the ethics and economics involved. We explored these issues in depth, and it was interesting to research science in a broader context. Miranda For the development of any new medicine, including nanomedicines, animal testing is a significant ethical issue to consider and I found that in addition to being a subject considered by those who carry out scientific research it is also a very contentious issue within the general public. I used what we had learnt in previous sessions in order to find factual arguments supported by data from reliable sources rather than arguments based on personal opinion. I found an interesting common theme of many articles was the need to consider how suitable animal models may actually be in studying the effects of nanomedicines on humans and the reasons why such models may fail. Owen Rachel Like with any new medical technology exploring unmapped territory, it was unsurprising to find a wealth of literature assessing the toxicological risks posed by nanomedicine. I found it useful to search for papers on the Web of Science database, refining my results by year (to include recent publications only) and type (peer-reviewed only) to streamline the mass of information I was confronted by. After reading a few papers, a unanimous message became clear: clinical trials are much needed, but a unique, comprehensive regulatory framework should be put in place first. Victoria Category:Meeting